Hydrocortisone sodium succinate parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections containing hydrocortisone.
Drugs List
Therapeutic Indications
Uses
Adrenal insufficiency - cortical
Inflammatory or allergic conditions
Shock - adrenal crisis
Status asthmaticus
Anti-inflammatory agent is indicated for any condition in which rapid and intense corticosteroid effect is required such as:
Endocrine disorders
Primary and secondary adrenal insufficiency
Collagen diseases
Systemic lupus erythematosus
Dermatological diseases
Severe erythema multiforme (Stevens-Johnson syndrome)
Allergic states
Bronchial asthma
Anaphylaxis (as adjunctive therapy to emergency treatment with
adrenaline)
Gastro-intestinal diseases
Ulcerative colitis
Crohn's disease
Respiratory diseases
Aspiration of gastric contents
Medical emergencies
Shock - adrenal crisis
Unlicensed Uses
Neonatal hypotension resistant to other treatment
Neonatal hypotension resistant to other treatment
Dosage
The preferred route for emergency use is by intravenous injection.
Following initial emergency use consider using a longer acting injectable or oral preparation.
Frequent patient review is required to titrate dose against disease activity.
In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilised, usually not beyond 48 to 72 hours.
Adults
Usual dosage range: 100mg to 500mg by intravenous injection over 1 to 10 minutes.
Doses may be repeated at 2, 4 and 6 hours as indicated by response and clinical condition.
The following alternative dosing schedules may be suitable:
Acute hypersensitivity reactions (adjunct to adrenaline)
100mg to 300mg by intravenous injection.
Adrenocortical insufficiency
100mg to 500mg by intramuscular injection, slow intravenous injection or infusion three or four times a day, or as required.
Severe inflammatory bowel disease
100mg to 500mg by slow intravenous injection or infusion three or four times a day, or as required.
Adrenocortical insufficiency resulting from septic shock
50mg by intravenous injection every 6 hours, given in combination with fludrocortisone.
Corticosteroid replacement, in minor surgical patients previously stabilised on the equivalent of greater than 10mg prednisolone daily within the last three months
25mg to 50mg by intravenous injection or infusion at the induction of surgery. Give the patient's usual corticosteroid dose after surgery.
Corticosteroid replacement, in moderate or major surgical patients previously stabilised on the equivalent of greater than 10mg prednisolone daily within the last three months
Initial dose: 25mg to 50mg by intravenous injection or infusion at the induction of surgery, after the patient's usual corticosteroid dose on the morning of surgery.
Maintenance dose: 25mg to 50mg by intravenous injection or infusion three times a day for 24 hours following moderate surgery and for 48 to 72 hours following major surgery.
Severe acute asthma
100mg by intravenous injection every 6 hours until conversion to oral prednisolone possible (in combination with other treatments).
Thyrotoxic crisis (thyroid storm)
100mg by intravenous injection every 6 hours.
Children
Dosage may be reduced in children but is guided more by condition severity than by age or weight.
The dose should not be less than 25mg daily.
The following alternative dosing schedules may be suitable:
Acute adrenocortical insufficiency (Addisonian crisis)
Children aged 12 to 18 years
100mg intravenously every 6 to 8 hours.
Children aged 1 month to 12 years
Initial dose: 2mg/kg to 4mg/kg as a slow intravenous injection or infusion
Maintenance dose: 2mg/kg to 4mg/kg every 6 hours. Titrate to response. Reduce over four to five days to oral maintenance dose when patient is stable.
Remission of inflammatory bowel disease
Children aged 2 to 18 years: 2.5mg/kg (maximum 100mg per dose) by intravenous injection every 6 hours OR 10mg/kg daily (maximum 400mg daily) by continuous intravenous infusion.
Acute hypersensitivity reactions; Angioedema
Children aged 12 to 18 years: 200mg intramuscularly or intravenously three times daily. Titrate according to response.
Children aged 6 to 12 years: 100mg intramuscularly or intravenously three times daily. Titrate according to response.
Children aged 6 months to 6 years: 50mg intramuscularly or intravenously three times daily. Titrate according to response.
Children aged 1 to 6 months: 25mg intramuscularly or intravenously three times daily. Titrate according to response.
Severe acute asthma
4mg/kg intravenously (maximum 100mg per dose) every 6 hours. This equates approximately to:
Children aged 5 to 18 years
100mg every 6 hours.
Children aged 2 to 5 years
50mg every 6 hours.
Children aged 1 month to 2 years
25mg every 6 hours.
Hypotension resistant to inotropic treatment and volume replacement (limited evidence) (unlicensed)
1mg/kg intravenously (maximum 100mg) every 6 hours.
Neonates
Acute adrenocortical insufficiency (Addisonian crisis)
Initial dose: 10mg as slow intravenous injection.
Maintenance dose: 100mg/metre squared daily as a continuous infusion or in divided doses every 6 to 8 hours. Titrate according to response. Reduce over four to five days to oral maintenance dose when the patient is stable.
Hypotension resistant to inotropic treatment and volume replacement (limited evidence) (unlicensed)
Initial dose: 2.5mg/kg intravenously, repeated if necessary after 4 hours.
Maintenance dose: 2.5mg/kg every 6 hours for 48 hours or until blood pressure recovers, then dose reduced gradually over a period of at least 48 hours.
Additional Dosage Information
Although uncommon, peptic ulceration can occur with high dose short term corticosteroids and acid suppression prophylaxis may be considered.
Patients subjected to severe stress following corticosteroid therapy should be observed closely for signs and symptoms of adrenocortical insufficiency.
Hydrocortisone withdrawal
Gradual withdrawal of therapy will be required in patients who have received more than 30mg hydrocortisone (approximate physiological dose) for greater than three weeks. Determine how dose reduction is to be carried out based on the likelihood of disease relapse on withdrawal and likelihood of hypothalamic-pituitary-adrenal (HPA) suppression. If disease is unlikely to relapse but hypothalamic-pituitary adrenal suppression is uncertain, a rapid reduction of dosage to 30mg daily may be effected, then dose reduction should be slowed down to allow the HPA-axis to recover.
Abrupt withdrawal of systemic hydrocortisone treatment which has continued up to 3 weeks is appropriate if it is considered that the disease is unlikely to relapse. Abrupt withdrawal of doses of up to 160mg daily of hydrocortisone for three weeks is unlikely to lead to clinically relevant HPA-axis suppression in the majority of patients.
In the following patient groups gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting three weeks or less:
a) Patients who have had repeated courses of systemic corticosteroids, especially if taken for greater than three weeks.
b) When a short course has been prescribed within one year of cessation of long term therapy.
c) Patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy.
d) Patients receiving doses greater than 160mg daily.
e) Patients repeatedly taking doses in the evening.
Administration
May be given by intravenous injection, intravenous infusion or intramuscular injection.
The preferred route for emergency use is by intravenous injection.
Contraindications
Uncontrolled systemic infection
Precautions and Warnings
Abscess
Children under 18 years
Elderly
Family history of diabetes mellitus
Family history of glaucoma
Predisposition to thrombophlebitis
Breastfeeding
Congestive cardiac failure
Corneal damage
Diabetes mellitus
Diverticulitis
Epileptic disorder
Gastrointestinal anastomosis
Glaucoma
Hepatic cirrhosis
Hepatic impairment
History of severe affective disorders
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Hypertension
Hypothyroidism
Myasthenia gravis
Ocular herpes simplex infection
Osteoporosis
Peptic ulcer
Pregnancy
Recent myocardial infarction
Renal impairment
Severe affective disorders
Thromboembolic disorder
Ulcerative colitis
Administration of live vaccines is not recommended
Consider increased dose during intercurrent illness/trauma/surgery
Consider reintroducing steroids temporarily during illness/trauma/surgery
Disease reactivation may occur in patients with latent TB
Exposure to measles may require prophylaxis with normal immunoglobulin
May mask symptoms or signs of infections
Consider prophylactic anti-tuberculosis therapy if appropriate
Passive immunisation of chicken pox / herpes zoster may be required
Premature infants: Perform cardiac evaluation and monitoring
Clinical presentations of infections may be atypical
Frequent review needed to titrate dose to disease activity
If visual disturbances occur, perform ophthalmic evaluation
Monitor regularly the height of children receiving prolonged treatment
Prolonged or high dose may lead to adrenal suppression
Psychological changes may occur during initiation & withdrawal of treatment
Supervise patient closely during drug withdrawal
Adrenal cortical atrophy may persist for years after stopping drug
Antibody response to vaccines may be reduced
Corticosteroids may cause growth retardation in children under 18 years
May cause activation of latent psychosis
May cause posterior subcapsular cataracts and glaucoma in long term use
Oversuppression of immune system may increase susceptibility to infection
Patient should report worrying psychological changes esp. suicidal thoughts
Potassium supplements may be required
Sudden withdrawal may be inadvisable -see product information/SPC
Maintain treatment at the lowest effective dose
Advise patient not to take St John's wort concurrently
Advise patient grapefruit products may increase plasma level
Dietary salt restriction may be necessary
Advise patient to avoid exposure to measles
Advise patient to seek urgent medical attention if exposed to measles
Advise those on systemic corticosteroids to avoid chickenpox/H zoster
Ensure patient receives Steroid Treatment/Steroid Emergency Card
If exposed to chickenpox or Herpes zoster seek urgent medical attention
In acute, life-threatening situations, administration of dosages exceeding the usual level may be justified. In these circumstances the slower rate of absorption by the intramuscular route should be noted.
High dose corticosteroids should be avoided in septic shock. However, there is evidence that low doses of hydrocortisone may be of benefit in adrenocortical insufficiency resulting from septic shock.
Patients (or parents of children) without a definite history of chicken pox should be advised to avoid close personal contact with chicken pox or herpes zoster and seek urgent medical attention if exposed as chicken pox can prove fatal in immunocompromised patients. If exposed while on dexamethasone or within three months of previous use, passive immunisation with varicella/zoster immunoglobulin (VZIG) should be administered within 10 days of the exposure. If chicken pox occurs, treat urgently under specialist care. Do not stop dexamethasone therapy, an upward dosage adjustment may be required.
Prolonged use of pharmacological doses of corticosteroids can lead to hypothalamic-pituitary-adrenal (HPA suppression). The duration and severity of adrenocortical insufficiency is dependant on dose, frequency, duration of glucocorticoid therapy and time of administration. Acute adrenal insufficiency may be fatal if glucocorticoid treatment is withdrawn too rapidly. A gradual reduction in dosage can help to minimise the effects of drug-induced secondary adrenocortical insufficiency. However, this type of relative insufficiency can persist for many months to years after treatment has been discontinued. Reinstitution of hormone therapy may be required in times of stress during this period.
Systemic corticosteroids should not be used to treat head injury or stroke because it is unlikely to be of any benefit and may even be harmful. A study has revealed an increased mortality at 2 weeks and 6 months after injury in patients administered with methylprednisolone sodium succinate compared to placebo.
Reported cases of hypertrophic cardiomyopathy was observed in premature infants after hydrocortisone administration, therefore cardiac function and structure should be monitored.
Pregnancy and Lactation
Pregnancy
Use hydrocortisone sodium succinate with caution during pregnancy.
The manufacturer recommends that hydrocortisone sodium succinate should only be used if the benefits to the mother and child outweigh the risks. When administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. Hypoadrenalism may occur in the neonate following prenatal exposure but usually resolves spontaneously following birth and is rarely clinically important.
Hydrocortisone readily crosses the placenta. Schaefer (2015) suggests that there is inconclusive evidence that corticosteroids result in an increased incidence of congenital abnormalities however, a possible association with oral clefts cannot be excluded.
When corticosteroids are essential, patients with normal pregnancies may be treated as though they were in the non-gravid state.
Lactation
Use hydrocortisone sodium succinate with caution during breastfeeding.
The manufacturer recommends that hydrocortisone sodium succinate should only be used during breastfeeding after an assessment of the benefits and risks to the mother and the infant. Infants of mothers taking higher doses may have a degree of adrenal suppression, but the benefits of breastfeeding are likely to outweigh any theoretical risk.
Corticosteroids are excreted in small amounts in breast milk, and both Schaefer (2015) and Briggs (2015) report that there are no reports to date of the use of hydrocortisone during breastfeeding. Schaefer recommends that prednisolone and methylprednisolone are the systemic corticosteroids of choice during breastfeeding.
Side Effects
Abdominal distension
Abscess (sterile)
Acne
Acute pancreatitis
Aggravation of schizophrenia
Amenorrhoea
Amnesia
Anaphylactoid reaction
Anaphylaxis
Anxiety
Aseptic necrosis
Avascular osteonecrosis
Behavioural disturbances
Blurred vision
Bowel perforation
Bronchospasm
Bruising
Cataracts
Cognitive impairment
Confusion
Congestive cardiac failure
Corneal thinning
Cushingoid facies
Cutaneous atrophy
Delusions
Depression
Dyspepsia
Ecchymosis
Emotional lability
Euphoria
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Exophthalmos
Gastro-intestinal haemorrhage
Glaucoma
Growth suppression in infancy, childhood and adolescence
Hallucinations
Hiccups
Hirsutism
Hypersensitivity reactions
Hypertension
Hypertrophic cardiomyopathy
Hypokalaemic alkalosis
Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
Impaired healing
Increase in serum alkaline phosphatase (reversible)
Increase in serum ALT/AST
Increased appetite
Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
Increased intra-ocular pressure
Increased susceptibility to infection
Increased sweating
Irritability
Kaposi's Sarcoma
Laryngeal oedema
Leucocytosis
Malaise
Mania
Menstrual disturbances
Muscle weakness
Myocardial rupture
Nausea
Negative calcium balance
Negative nitrogen balance
Oesophageal candidiasis
Oesophageal ulceration
Opportunistic infections
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Petechiae
Potassium loss
Proximal myopathy with wasting and weakness
Psychological dependence
Psychosis
Pulmonary embolism
Recurrence of dormant tuberculosis
Scleral thinning
Seizures
Skin atrophy
Skin pigmentation changes
Sleep disturbances
Sodium/water retention
Striae
Subcutaneous atrophy
Suicidal tendencies
Suppression of clinical signs of infection
Suppression of reactions to skin tests
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Tendon rupture
Thromboembolism
Thrombosis
Urticaria
Vertebral and long bone fractures
Weight gain
Withdrawal symptoms
Withdrawal Symptoms and Signs
Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. A `withdrawal syndrome' may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and weight loss.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last review date: November 2020
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Solu-Cortef. Pfizer Limited. Revised August 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 November 2020
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